510(k) K003412
K003412 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "ADVIA CENTAUR RUBELLA IGG ASSAY". The FDA issued a decision of Substantially Equivalent on April 13, 2001. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2001
- Date Received
- November 2, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type